Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03667326

Postpartum Low-Dose Aspirin and Preeclampsia

The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Aleha Aziz, MD, MPH

CONTACT

[email protected]

646-678-0289

Aleha Aziz, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with the condition are at increased risk for complications during pregnancy, including seizures - eclampsia. Babies are at risk of being born premature because the only cure for preeclampsia is delivery. Women who have had preeclampsia are also at increased risk of cardiovascular and kidney disease later in life, including heart attack, stroke and high blood pressure. Studies show that women at high risk for preeclampsia, i.e., have had preeclampsia in a prior pregnancy, are carrying more than one fetus, have a history of high blood pressure, kidney disease or both, have certain medical problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.

Due to the limited data available on the topic of LDA in preeclamptic patients in the postpartum period, particularly as applicable to the American population, the investigator intends to start with a small pilot study involving the collection of information on 10 women not exposed to study intervention. This will allow for confirmation of the sample size based on the baseline FMD measurements 2 days after delivery.

Investigator will also explore a small sub-study to gather information regarding baseline FMD and biomarker values for healthy control postpartum patients, unaffected by preeclampsia and not on LDA during pregnancy or postpartum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton or Multiple gestation
  • Maternal age >= 18 years
  • 20 0/7 weeks gestation or greater
  • Severe Preeclampsia diagnosed prior to delivery

Exclusion criteria

  • Aspirin use postpartum for other medical indication
  • Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)
  • Aspirin use within 7 days of planned initial FMD testing postpartum
  • Hypersensitivity or allergy to Aspirin or other salicylates
  • Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
  • Nasal polyps
  • Gastric or Duodenal ulcers, history of GI bleeding
  • Severe hepatic dysfunction
  • Bleeding disorders and diathesis
  • Breastfeeding a newborn with low platelets (NAIT)

For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion for healthy controls group).

Treatment and study plan

Aspirin tablet

Drug

Low dose aspirin, 81mg tablets, PO

Other names: Aspirin

Placebo oral capsule

Drug

Placebo oral capsule, PO

Other names: Placebo

Primary outcomes

  1. Change in Flow-Mediated Dilation (FMD)

    Time frame: Up to 3 weeks postpartum

    This is designed to measure if patients with preeclampsia with severe features diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 3 weeks after delivery when taking daily LDA in the postpartum period.

Secondary outcomes

  1. Change in Systolic blood pressure

    Time frame: Within 3 weeks postpartum

    This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.

  2. Change in Diastolic blood pressure

    Time frame: Within 3 weeks postpartum

    This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.

  3. Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities)

    Time frame: Up to 3 weeks postpartum

    This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.

  4. Magnesium sulfate re-administration

    Time frame: Up to 3 weeks postpartum

    This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum again when taking daily LDA in the postpartum period?

  5. Number of subjects with initiation of, increase in or addition of blood pressure medication

    Time frame: Up to 3 weeks postpartum

    This is to measure if patients will experience a decreased rate in initiation of/ increase in/ addition of blood pressure medication postpartum when taking daily LDA in the postpartum period.

  6. Rate of hospital readmissions for postpartum preeclampsia

    Time frame: Up to 3 weeks postpartum

    This is to measure if patients will experience a decreased rate of hospital readmissions for postpartum preeclampsia when taking daily LDA in the postpartum period.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleha Aziz, MD, MPH

CONTACT

[email protected]

646-678-0289

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2018
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.